Quality Engineer, MedTech - CAPA & Process Validation

Becton Dickinson; El Paso (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

BD in El Paso, Texas is hiring a quality engineer to provide manufacturing quality support ensuring FDA/ISO/GMP compliance. You will lead investigations into nonconformances, CAPAs, and audit findings, while collaborating with cross-functional teams to improve processes and product quality.

You will develop and validate inspection methods, participate in change control, and support regulatory submissions and inspections.

Qualifications

• Bachelor’s degree in Engineering; four years of engineering or quality engineering in medical devices.
• Master’s degree in Engineering; two years experience acceptable.
• English in written and spoken form; bilingual English/Spanish preferred.

Responsibilities

• Provide quality engineering support for manufacturing processes to ensure FDA/ISO/GMP compliance.
• Lead investigations of nonconformances, deviations, complaints and CAPA.
• Develop and validate inspection and test methods.
• Participate in change control activities and risk assessment.
• Support regulatory submissions and inspections.
• Promote a culture of quality and continuous improvement.

Skills

FDA QSR 21 CFR 820

CAPA & root cause analysis

Process validation

Risk management (ISO 14971)

Statistical analysis

Lean manufacturing

Change control

Technical writing

Cross-functional collaboration

Audits & regulatory inspections

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Job description

BD in El Paso, Texas is hiring a quality engineer to provide manufacturing quality support ensuring FDA/ISO/GMP compliance. You will lead investigations into nonconformances, CAPAs, and audit findings, while collaborating with cross-functional teams to improve processes and product quality.

You will develop and validate inspection methods, participate in change control, and support regulatory submissions and inspections.